Drugs / Enfuvirtide
Enfuvirtide
also known as
Fuzeon · T20 · DP-178 · ENF · Enfuvirtida · Fuzeon (T-20) · Pentafuside (trivial name) · Ro 29,9800
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | FUZEON | — | 2004-10-15 – 2011-04-28 | fda.gov ↗ |
| Approved | EU (EMA) | Fuzeon | — | 2003-05-27 | europa.eu ↗ |
| Approved | US (FDA) | FUZEON | — | 2003-03-13 | fda.gov ↗ |
Trials 29
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT01836068 | Jun 2013 → Jan 2020 | HIV infectious disease | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT00312546 | Jun 2006 → Apr 2009 | HIV infectious disease | University of North Carolina, Chapel Hill | Terminated | No outcome recorded |
| Phase 1 | NCT00001118 | ? → Dec 2002 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00086710 | — | AIDS | Trimeris | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT00615134 | Jan 2008 → Jun 2011 | HIV infectious disease | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT00120367 | Apr 2005 → Dec 2007 | HIV infectious disease, progressive multifocal leukoencephalopathy | French National Agency for Research on AIDS and Viral Hepatitis | Completed | No outcome recorded |
| Phase 2 | NCT00022763 | Aug 2001 → Dec 2004 | HIV infectious disease | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT00002239 | May 1999 → ? | HIV infectious disease | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT00002228 | — | HIV infectious disease | Trimeris | Completed | No outcome recorded |
| Phase 2/31 trial · 1 missed | ||||||
| Phase 2/3 | NCT00624195 | Mar 2007 → Feb 2012 | HIV infectious disease | University of California, San Diego | Completed | Missed primary |
| Phase 37 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT00537394 | Jan 2008 → May 2012 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Met primary |
| Phase 3 | NCT00454337 | May 2007 → Sep 2008 | HIV infectious disease | French National Agency for Research on AIDS and Viral Hepatitis | Completed | Met primary |
| Phase 3 | NCT00302822 | Apr 2006 → Dec 2009 | AIDS | French National Agency for Research on AIDS and Viral Hepatitis | Completed | Missed primary |
| Phase 3 | NCT02733419 | Dec 2004 → Mar 2008 | HIV infectious disease | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00050856 | Nov 2002 → Nov 2003 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 3 | NCT00021554 | — | HIV infectious disease | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00008528 | — | HIV infectious disease | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 410 trials | ||||||
| Phase 4 | NCT00488059 | Jun 2007 → Oct 2008 | HIV infectious disease | Hoffmann-La Roche | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00461266 | Apr 2007 → Jan 2008 | HIV infectious disease | Hoffmann-La Roche | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00487188 | Nov 2005 → Nov 2007 | HIV infectious disease | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT00657761 | Sep 2005 → Mar 2006 | HIV infectious disease | Hospital Clinic of Barcelona | Completed | No outcome recorded |
| Phase 4 | NCT02569502 | Apr 2005 → Oct 2007 | HIV infectious disease | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT00344760 | Jan 2005 → Mar 2007 | HIV infectious disease | University of Maryland, Baltimore | Completed | No outcome recorded |
| Phase 4 | NCT00100984 | Jul 2004 → Jul 2005 | HIV infectious disease | Hoffmann-La Roche | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00232908 | Jun 2004 → Oct 2005 | HIV infectious disease | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT02582983 | Feb 2004 → Dec 2009 | HIV infectious disease | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT00192660 | Feb 2003 → Oct 2006 | cardiovascular disorder, lipodystrophy | Kirby Institute | Completed | No outcome recorded |
| Phase not applicable2 trials · 1 missed | ||||||
| — | NCT00051831 | Oct 2003 → Dec 2007 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| — | NCT00102934 | Mar 2003 → Dec 2005 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Unknown | No outcome recorded |
| Comparator or background therapy11 trials | ||||||
| Phase 1/2 | NCT00031044 Background | ? → Nov 2004 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Phase 2 | NCT00460382 Background | May 2007 → Mar 2008 | HIV infectious disease | French National Agency for Research on AIDS and Viral Hepatitis | Completed | No outcome recorded |
| Phase 2 | NCT00128830 Background | Jun 2005 → Aug 2008 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 2 | NCT00089492 Comparator | Jul 2004 → Jun 2006 | HIV infectious disease | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT02302547 Comparator | Dec 2014 → Aug 2017 | HIV infectious disease | University Hospital, Tours | Completed | No outcome recorded |
| Phase 3 | NCT00708162 Background | Jul 2008 → Dec 2010 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT00440271 Background | Feb 2007 → Oct 2008 | HIV infectious disease | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 4 | NCT00337701 Background | Jun 2006 → Jan 2007 | HIV infectious disease | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT00326963 Background | Mar 2006 → Apr 2007 | HIV infectious disease | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT00233883 Comparator | Aug 2005 → Jul 2006 | HIV infectious disease | Hoffmann-La Roche | Completed | No outcome recorded |
| — | NCT00334022 Comparator | Feb 2006 → Jul 2007 | — | Canadian Immunodeficiency Research Collaborative | Completed | No outcome recorded |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 42 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | enfuvirtide | “Generic names: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine,...” NCT00624195 ↗38“enfuvirtide is the lead compound in the new class of antiretroviral drugs which inhibit the fusion of HIV-1 virus with its target cell.” NCT00454337 ↗ “Tenofovir+Emtricitabine+Third agent (Including a fusion inhibitor: enfuvirtide or a CCR5 antagonist :maraviroc” NCT02302547 ↗ “didanosine, emtricitabine (FTC), enfuvirtide, Epzicom® (ABC/LAM coformulated)” NCT00708162 ↗ “optimized background therapy: may include NRTI(s) and enfuvirtide” NCT00460382 ↗ “Enfuvirtide,” NCT00440271 ↗ |
| Known as | DP-178 | ChEMBL registry synonym — accepted as the source's own label CHEMBL525076 ↗ |
| Known as | ENF | “Enfuvirtide (ENF)” NCT00128830 ↗ |
| Known as | Enfuvirtida | ChEMBL registry synonym — accepted as the source's own label CHEMBL525076 ↗ |
| Known as | Fuzeon | “The aim of this open-label multicentre study is to estimate the effect of an early therapy intensification based on potent antiretroviral combination including...” NCT00120367 ↗11“This study will determine the safety and tolerability of Fuzeon (enfuvirtide) used together with other treatments for HIV infection in patients with advanced HIV disease.” NCT00050856 ↗ “Fuzeon® (enfuvirtide) 90 milligram (mg) subcutaneously (SC) two times a day (bid)” NCT00326963 ↗ “enfuvirtide [Fuzeon]” NCT00089492 ↗ “enfuvirtide [Fuzeon]” NCT00461266 ↗ “enfuvirtide [Fuzeon]” NCT00232908 ↗ “enfuvirtide [Fuzeon]” NCT00488059 ↗ “FUZEON [enfuvirtide]” NCT00100984 ↗ “enfuvirtide [Fuzeon]” NCT00337701 ↗ “enfuvirtide [Fuzeon]” NCT00233883 ↗ “enfuvirtide [Fuzeon]” NCT00615134 ↗ |
| Known as | Fuzeon (T-20) | “Fuzeon (T-20)” NCT00344760 ↗ |
| Known as | Pentafuside (trivial name) | ChEMBL registry synonym — accepted as the source's own label CHEMBL525076 ↗ |
| Known as | Ro 29,9800 | “Fuzeon (Enfuvirtide T-20/Ro 29,9800, HIV-1 Fusion Inhibitor)” NCT00050856 ↗ |
| Known as | T20 | “A Randomized Phase I/II Placebo-controlled Study of Amdoxovir (DAPD) Versus Placebo Together With Enfuvirtide (T-20) Plus Optimized Background Therapy for HIV-Infected Subjects...” NCT00031044 ↗4“The metabolic effects of T-20 are not completely known, since the drug is used in combination with other antiretroviral agents.” NCT00657761 ↗ “Fuzeon (Enfuvirtide T-20/Ro 29,9800, HIV-1 Fusion Inhibitor)” NCT00050856 ↗ “T-20 (HIV-1 Fusion Inhibitor)” NCT00008528 ↗ “enfuvirtide (T20)” NCT00192660 ↗ |
| Action | Inhibit | “specifically inhibits the function of the gp41 transmembrane glycoprotein of HIV-1.” NCT00050856 ↗ |
| Modality | Peptide | “Enfuvirtide, a peptide inhibitor of human immunodeficiency virus (HIV)-1-host cell membrane fusion” PMID 15295220 ↗ Aug 2004 |
| Route | Subcutaneous | “subcutaneous infusion” NCT00002228 ↗ |